Specialist - Quality Operations

REQ-10015156
Sep 03, 2024
India

Summary

-Manages Quality aspects and projects within area of responsibility. -Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.  

About the Role

Major accountabilities:

  • Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance -Support exception investigations -Review and approval of production, QC, and AS and T records -MBR review -Support OpEx improvement projects Qualified Person – Executes batch release in compliance with registration -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Key performance indicators:

  • On-time and GMP-compliant release of dosage forms -No complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand -Successfully support continuous improvement projects -Executes batch release in compliance with registration  

Minimum Requirements:
Work Experience:

  • Functional Breadth.
  • QC/ QA in pharmaceutical ind./ biotech with environmental monitoring &.
  • Collaborating across boundaries.
  • cleanliness zones.

Skills:

QMS

BMR/ BPR review

Batch Release process

Quality Management

Regulatory compliance checks

 

Languages :

  • English.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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Operations
Innovative Medicines
India
Hyderabad (Office)
Telangana, India
Quality
Full time
Regular
No

Accessibility and accommodation

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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REQ-10015156

Specialist - Quality Operations

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